Senior Technical Officer, Quality Assurance/Quality Control (QA/QC)- USP
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
The Promoting the Quality of Medicines Plus (PQM+) program, funded by USAID and implemented by USP, improves access to quality-assured priority medicines and addresses the proliferation of poor- quality medical products in low- and middle-income countries. PQM+ will strengthen medical product quality assurance systems through cross-sectoral and systems strengthening approaches and the application of international quality assurance standards across the pharmaceutical system. By sharing scientific expertise and providing technical support and leadership, PQM+ helps create resilient and robust local health systems that address diseases like HIV/AIDS, tuberculosis, malaria and neglected tropical diseases, as well as improves maternal, newborn and child health.Under the guidance of the Chief of Party, the Senior Technical Officer, QA/QC will provide technical assistance to the Department of Drug Administration (DDA) and private sector quality control laboratories to build their capacity to ensure the quality of medical products circulating in Nepal. S/he must possess a deep understanding of the pharmaceutical regulatory environment in low income and middle-income countries to provide technical oversight for strengthening the capacity of laboratories responsible for assessing the quality of medical products and vaccines.
Scope of Work:
- Facilitates the development of in-house training programs to ensure sustainability and transfer of knowledge within public and private laboratories
- Advises on the interventions to address institutional development plans based on the findings of the WHO Global benchmarking assessment related to laboratory testing
- Supports the roll-out of risk-based post marketing surveillance and the uptake and application of the MedRS tool
- Provide technical assistance for ISO 17025 accreditation and/or WHO prequalification by assessing, auditing, preparing and reviewing laboratory processes and procedures
- Assist in preparation of quality control laboratories for WHO inspections, including assistance in strengthening QMS procedures to prepare for WHO inspections, conducting of mock audits and preparation of laboratory information files to be submitted to WHO.
- Assist laboratories during WHO inspections and in the development and implementation of CAPA plans
- Provide oversight of local and regional partners and consultants involved in laboratory activities
- Keep abreast of the latest regulatory trends and WHO guidance
- May manage and mentor junior technical staff
- Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports
- Minimum of 8 + years of relative experience in pharmaceutical quality control testing with public or private laboratories.
- Bachelor’s degree in pharmacy, pharmaceutical science, chemistry, engineering or science related field of study required
- Working knowledge and understanding of regulatory systems strengthening in Nepal with an emphasis on Quality Assurance/Quality Control of medical products
- Strong written (especially technical writing) and oral communication skills
- Willingness to travel at least 25% of the time.
- Minimum of 3+ years people management experience and skills
- Direct experience implementing USAID-funded programs
- Direct experience with and understanding of WHO global benchmarking tool
- Experience in at least one of the following health areas: HIV/AIDS, malaria, TB, NTDs, AMR, MNCH
Interested candidates should submit cover letter, CV, and USAID Form 1420 (available at https://www.usaid.gov/forms/aid-1420-17) by email to GPHNepalRecruitment@USP.org clearly stating Senior Technical Officer QA/QC in the subject line of the e-mail.
Cover letter, CV, and USAID Form Click here for Download
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